ICH releases revised Q9 guideline to improve risk assessments

Regulatory NewsRegulatory News | 03 January 2022 |  By 

The International Council for Harmonization (ICH) issued a revision of the Q9 guideline that aims to address the shortcomings of the current guideline. The goal of the revision is to provide “more scientific and robust applications of quality risk management principles (QRM)” leading to “fewer quality defects and recalls” and reduced costs for the pharmaceutical industry, according to an ICH business plan.
The ICH Q9(R1) guideline was published on the European Medicines Agency (EMA) website on 16 December, following ICH endorsement of the revision in mid-November. EMA is accepting comments until 15 March 2022.
The document updates the original ICH Q9 guideline, which is now 16 years old. Plans are to issue a Step 4 guideline by June 2022. Official training materials are being developed in advance of the completion of Step 4.
According to a Step 2 presentation of the guidance, the revision is intended to address four shortcomings of the current document:
  • High levels of subjectivity in risk assessments and in QRM outputs
  • Failure to adequately manage supply chain and product availability risks
  • Lack of understanding as to what constitutes formality in QRM work
  • Lack of clarity on risk-based decision making
Adoption of a revised guideline would result in “more scientific and robust applications of QRM principles, tools, and activities, where subjectivity in QRM outputs is better controlled. This could lead to more science-based manufacturing operations, control strategies, and validation activities, which may result in fewer quality defects and recalls for patients, and potentially in reduced costs for the pharmaceutical industry and healthcare systems,” according to the ICH business plan.
New text on subjectivity
The revised guideline introduces new text acknowledging that some degree of subjectivity in QRM is unavoidable while offering methods to reduce or control subjectivity. The guideline states that “while subjectivity cannot be completely eliminated from quality risk management activities, it may be controlled by addressing bias, the proper use of quality risk management tools and maximising the use of relevant data and sources of knowledge.”
All personnel involved with QRM activities should “acknowledge, anticipate, and address the potential for subjectivity,” according to the revised guidance. Furthermore, decision-makers should ensure that such subjectivity is “controlled and minimised” to allow for more “robust risk-based decision making.”
Formality addressed in guideline
The revision also includes a new section on formality in quality risk management. According to the ICH presentation of the guideline, there is a “lack of understanding as to what constitutes formality in QRM, and how this area has the potential to be further developed to lead to a more effective application of QRM principles.”
The guideline states that “an understanding of formality in quality risk management … may lead to resources being used more efficiently, where lower risk issues are dealt with via less formal means, freeing up resources for managing higher risk issues and more complex problems that may require increased levels of rigour and effort.”
Further, according to the new section, “the more important a risk-based decision is, the higher the level of formality that should be applied, and the greater the need to reduce the level of uncertainty associate with it.”
The revision also has new text on the role of quality risk management in addressing product availability risks. It states that “quality/manufacturing issues, including non-compliance with Good Manufacturing Practice (GMP), are a frequent cause of product availability issues (e.g., product shortages). The interests of patients are served by risk-based drug shortage prevention and mitigation activities that help to proactively manage supply chain complexities and ensure availability of needed medicines. An effective pharmaceutical quality system drives both supply chain robustness and sustainable GMP compliance.”
Risk-based decision-making is also addressed in the revisions to ICH Q9, with new clarity on how factoring an assessment of risk into decisions can be beneficial. “This facilitates informed decisions in a multitude of areas, including when allocating resources,” according to the Step 2 presentation.
Within the revised guideline, the term “Risk Identification” has been replaced with “Hazard Identification,” to harmonize with discussion in the risk assessment portion of the guidance. The section on risk review, however, remains unchanged.
ICH Q9 revision


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Tags: assessments, ICH, Q9, risk

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